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Zimmer MotionLoc Screws, when used with the Periarticular Locking Plate System are indicated for temporary internal fixation and stabilization of osteotomies and fractures of long bones, including:

• Comminuted fractures
• Supracondylar fractures
• Intra-articular and extra-articular condylar fractures
• Fractures in osteopenic bone
• Nonunions
• Malunions

The Zimmer MotionLoc Screw for Periarticular Locking Plate System is used in conjunction with the Zimmer Periarticular Locking Plate (ZPLP) System. It is a member of the ZPLP Screw family and is used as an alternative for standard ZPLP Screws in applications where a surgeon desires reduced stiffness in a construct.

Zimmer MotionLoc technology has been developed to reduce the stiffness of locked plating constructs while retaining construct strength. This Zimmer MotionLoc technology relies on a screw design with a reduced diameter mid-section. These screws provide uni-cortical fixation in the far cortex of a diaphysis and are locked into the plate, without being rigidly fixed in the near cortex underlying the plate. The screw mid-section decreases the stiffness of the plating construct by acting as an elastic cantilever beam similar to a half-pin of an external fixator.

The Zimmer MotionLoc Screw for Periarticular Locking Plate System has a standard ZPLP Screw front thread section (self-tapping, single helix); an expansion section, intended to create the gap for motion in the near cortex; a mid-section thread with a reduced core-diameter and reverse cutting flutes to aid in screw removal, especially once the front thread screw section is out of the far cortex; a non-threaded collar section; and a double lead threaded head for engagement in the plate.

Here's an analysis of the provided text regarding the Zimmer MotionLoc Screw for Periarticular Locking Plate System, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state specific numerical acceptance criteria (e.g., minimum torque to failure in Nm, or fatigue cycles). Instead, it broadly states that the "results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective for their intended use and substantially equivalent to the predicate devices." This implies that the performance met internal benchmarks or demonstrated equivalence to the predicate's known performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "physical testing" and various types of tests (torsional fatigue, axial fatigue, starting load, driving torque, torque to failure), but does not provide the number of samples or specimens tested for each.
• Data Provenance: The studies were non-clinical (lab) performance testing. The country of origin is not specified, but the sponsor is Zimmer, Inc. (USA), and the submission is to the FDA (USA). The data is prospective in the sense that the tests were conducted specifically to evaluate this device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. This was a non-clinical (lab) performance study of a bone screw. Ground truth in this context refers to engineering specifications and material science principles, not expert medical opinion on, for example, image interpretation. There was no "test set" requiring human expert ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis.

4. Adjudication Method for the Test Set

• Not Applicable. As this was a non-clinical, lab-based performance study, there was no need for adjudication of human interpretations or diagnoses. The results are objective measurements from mechanical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study was not conducted. This type of study involves human readers evaluating medical cases, often with and without AI assistance. The submitted device is a physical bone screw, not an AI software or a diagnostic tool that interacts with human readers in that manner.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, in spirit. The "Performance Data (Nonclinical)" section describes the standalone performance of the device itself through various mechanical tests. These tests assess the device's inherent properties and behavior without human intervention in operating or interpreting the device's output (beyond setting up the test and collecting data). The device itself (the screw) is the "algorithm" here, and its performance is measured directly.

7. Type of Ground Truth Used

• Engineering Specifications / Mechanical Properties: The "ground truth" for this study is derived from established engineering principles, material science, and the mechanical performance characteristics of the predicate devices. The implicit target is that the Zimmer MotionLoc Screw meets or exceeds the mechanical requirements for its intended use and is comparable to previously cleared predicate devices.

8. Sample Size for the Training Set

• Not Applicable. This refers to a physical medical device, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set mentioned or implied for this physical device.

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